FDA product code QQT: Immunohistochemistry Assay, Antibody, Ki-67
QQT is the FDA product code for immunohistochemistry assay, antibody, ki-67. It is a Class III device, reviewed by the Pathology panel. Devices under QQT reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Assay, Antibody, Ki-67 |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QQT devices
openFDA lists no recalls for product code QQT.
Frequently asked questions
What is FDA product code QQT?
QQT is the FDA product code for immunohistochemistry assay, antibody, ki-67. It is a Class III device, reviewed by the Pathology panel.
What device class is QQT?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QQT
- Run a recall and safety report across every QQT manufacturer
- Watch product code QQT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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